UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034551 |
|---|---|
| Receipt number | R000039387 |
| Scientific Title | An investigation study of measuring the glycemic index (GI): non-randomized single administration study |
| Date of disclosure of the study information | 2018/10/17 |
| Last modified on | 2019/03/31 13:55:51 |
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Basic information
Public title
An investigation study of measuring the glycemic index (GI): non-randomized single administration study
Acronym
An investigation study of measuring the glycemic index (GI)
Scientific Title
An investigation study of measuring the glycemic index (GI): non-randomized single administration study
Scientific Title:Acronym
An investigation study of measuring the glycemic index (GI)
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the glycemic index (GI) of the test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
GI
* Based on ISO 26642
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: single dose
Test Material: test food
Dose: 204 g (50g of carbohydrate amount)
Administration: Eat the test food with water (300 mL) within 12-15 minutes
Duration: single dose
Test Material: 50 g of glucose solution
Dose: 150 mL
Administration: Take the solution within 12-15 minutes
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult subjects ages between 20-50 years
2. Subjects who are below 30 kg/m2 in BMI
3. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have food allergies and/or food intolerances
5. Subjects who take medications known to affect glucose tolerance
6. Subjects who use insulin to treat diabetes or take antihyperglycemic drugs
7. subjects who are the presence of disease or drugs which influence digestion and absorption of nutrients
8. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
9. Subjects who are currently taking medications (including herbal medicines) and dietary supplement. Particularly, the use of steroids, protease inhibitors, or antipsychotics
10. Subjects who are an allergic reaction to medications and/or the test food related products. Particularly, the presence of celiac disease or sensitive to gluten
11. Subjects who are pregnant, breast-feeding, or planning to become pregnant
12. Subjects who have a major medical or surgical event requiring hospitalization within the preceding 3 months
13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trials during trial period
14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
TEIJIN LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
11
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039387
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| Registered date | File name |
| Research case data | |
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